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美国药品短缺应对机制及其对我国的启示 被引量:4

The Coping Mechanism of Drug Shortage in the US and Its Inspiration to China
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摘要 目的:对美国药品短缺应对机制进行研究,总结其经验,为我国药品短缺应对提供借鉴和思路。方法:采用文献研究法了解美国处理药品短缺的具体情况,运用对比分析法寻找我国可以采纳的优点。结果:美国的药品短缺应对机制相对完善,有专门的管理机构,并且通过政策法规等文件明确规定了药品短缺的解决流程,能够有效地改善药品短缺问题。结论:我国可以参考美国的处理方式,明确药品短缺的具体概念,完善药品短缺管理法律法规,设立专门的管理机构,建立短缺信息监测机制等。 Objective: To analyze the coping mechanism of drug shortage in the US, to summarize its experience so as to provide references for dealing with drug shortage in China. Methods: The detail of the coping mechanism of drug shortage in the US was analyzed with the method of literature research. The advantages that can be adopted by China were found out through comparative analysis. Results: The coping mechanism of drug shortage in the US is relatively perfect. There being a specialized management organization to handle the problem and there being some policies and regulations to specify the process can improve the situation of drug shortage effectively. Conclusion: In China, the concept of drug shortage should be defined, the laws and regulations on drug shortage should be improved, the specialized organization should be set up, and the shortage information monitoring mechanism should be established according to the coping mechanism of drug shortage in the US.
出处 《中国药事》 CAS 2017年第8期838-842,共5页 Chinese Pharmaceutical Affairs
基金 工信部委托课题我国短缺药品供应保障研究(编号X153030-2)
关键词 药品短缺 应对机制 经验启示 管理机制 政策法规 信息监测 drug shortage coping mechanism experience and inspiration management mechanism policies and regulations information monitoring
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  • 1FDA. A Review of FDA's Approach to Medical Product Shortages. http://www, fda. gov/downloads/AboutFDA/ Re- portsManualsForms/Reports/UCM277755, pdf.
  • 2FDA. Manual of Policies and Procedures Drug Shortage Man- agement, http://www, fda. gov/downloads/AboutFDA/ Cent ersOf fices/OfficeofMedicalProduct sandTobaeco/CDER/ ManualofPoliciesProcedures/UCM079936. pdf.
  • 3ASHP. ASHP Guidelines on Managing Drug Product Shorta- ges. http..//www, ashp. org/s_ashp/docs/files/BP07/Procure_ Gdl_Shortages. pdf.
  • 4ASHP. Sample Drug Shortages Policy by University Health care Hospitals and Clinics. http://www, ashp. org/DocLi brary/Poliey/DrugShor tages/UUHC-DrugShort agePoliey, as px.
  • 5FDA division of manufacturing and quality office of compliance. Manual of policies and procedure of drug shortage management [EB/OL] .http://www .fda. gov/ cder/mapp/4730- 1.pdf. 1995- 11- 13. 2007- 06- 06.
  • 6FDA. Drug Shortages: Frequently Asked Questions [ EB/OL ] . http ://www. fda.gov/cder/drug/short- ages/faq, htm. 2005 - 05 - 25. 2007 - 06 - 06.
  • 7FDA. URGENT Naloxone Hydrochloride Injection Status [EB/ OL] . http:// www.fda.gov/ medwatch/ SAFETY/ 2001/ naloxone ,htm.2001 - 04- 04.2008- 04- 04.
  • 8Tamar Nordenberg. Inside FDA : When a Drug Is in Short Supply [ EB/OL ] . http ://www. fda. gov/fdac/ features/ 1992/ 797_drug. html. 1997 - 04 - 02. 2007- 06- 06.
  • 9Reuters. Glaxo Has New Shortage of Diabetes, Heart Drugs [ EB/OL ] . http ://www, medseape, coral viewar- title/521297.1997 - 04 - 02. 2007 - 06 - 06.
  • 10FDA. Drug shortage [ EB/OL ] . http ://www. fda. gov/ CDER/DRUG/shortages/default. htm. 1997 - 04 - 02. 2007 - 06 - 06.

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